Generic Name: belatacept (bel-AT-a-sept)
Brand Name: Nulojix
Nulojix weakens your immune system. This may increase the risk of cancer or serious and sometimes fatal infections. Tell your doctor right away if you notice symptoms of infection (eg, fever, chills, persistent sore throat), a change in the size or appearance of a mole, or unusual lumps or growths.
Nulojix may increase the risk of a condition called posttransplant lymphoproliferative disorder (PTLD), especially in the brain. PTLD may lead to cancer and may be fatal. Your risk may be increased if you are infected with a virus called cytomegalovirus (CMV). It may also be increased if you use medicine that suppresses certain parts of the immune system. It may also be increased if you have never been exposed to a virus called the Epstein-Barr virus (EBV). You will be tested before you use Nulojix to see if you have been exposed to EBV. Do not use Nulojix if you have never been exposed to EBV.
Tell your doctor right away if you develop symptoms such as mental or mood changes (eg, behavior changes, confusion, memory problems, trouble thinking), decreased strength or weakness on one side of the body, trouble walking or talking, or vision changes. Discuss any questions or concerns with your doctor.
Use of Nulojix in liver transplant patients is not recommended. There is an increased risk of transplant loss and death.
Nulojix is used for:
Preventing organ rejection after a kidney transplant in certain patients. It is used with other medicines.
Nulojix is a selective costimulation blocker. It works by stopping the immune system from attacking healthy tissues in the body.
Do NOT use Nulojix if:
- you are allergic to any ingredient in Nulojix
- you have not been exposed to EBV or if it is unknown whether you have been exposed to it
- you have had a liver transplant
Contact your doctor or health care provider right away if any of these apply to you.
Before using Nulojix:
Some medical conditions may interact with Nulojix. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have CMV infection, herpes infection, or any other infection (eg, bacterial, fungal, protozoal, viral)
- if you have tuberculosis (TB) or a positive skin test for TB, or you have recently been in close contact with someone who has had TB
- if you have blood cell problems (eg, anemia, low white blood cell levels), blood electrolyte problems (eg, high or low blood potassium levels), diabetes, or high blood pressure
- if you have a history of cancer (eg, skin cancer)
- if you have had an organ transplant other than a kidney (eg, liver)
- if you are scheduled to receive a vaccination
Some MEDICINES MAY INTERACT with Nulojix. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Live vaccinations because their effectiveness may be decreased by Nulojix
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nulojix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Nulojix:
Use Nulojix as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Nulojix comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Nulojix refilled.
- Nulojix is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Nulojix at home, a health care provider will teach you how to use it. Be sure you understand how to use Nulojix. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Nulojix if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you miss a dose of Nulojix, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Nulojix.
Important safety information:
- Nulojix may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Nulojix with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
- Nulojix may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection such as fever, sore throat, rash, or chills.
- Tell your doctor or dentist that you use Nulojix before you receive any medical or dental care, emergency care, or surgery.
- Do not receive a live vaccine (eg, measles, mumps) while you are using Nulojix. Talk with your doctor before you receive any vaccine.
- You may need to have a TB skin test before you begin using Nulojix. Contact your doctor with any questions you may have about whether you should receive a TB skin test before using Nulojix.
- Nulojix may increase your risk of developing cancer, including skin cancer. To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Discuss with your doctor any questions or concerns about increased cancer risk.
- Some patients treated with Nulojix have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or BK virus infection. BK virus infection may cause kidney problems or loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine).
- Patients who take Nulojix may have an increased risk of developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Lab tests, including EBV serotype, kidney function, and TB, may be performed while you use Nulojix. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Nulojix should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nulojix while you are pregnant. It is not known if Nulojix is found in breast milk. Do not breast-feed while using Nulojix.
Possible side effects of Nulojix:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; headache; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the appearance or size of a mole; decreased strength or weakness on one side of your body; fainting; fever, chills, or persistent sore throat; flu-like symptoms; mental or mood changes (eg, behavior changes, confusion, memory problems, trouble thinking); mouth sores or inflammation; new or worsening cough; night sweats; severe or persistent headache or dizziness; shortness of breath; severe or persistent diarrhea, nausea, or vomiting; stomach pain; swelling of the hands, ankles, or feet; swollen glands; symptoms of high or low blood potassium levels (eg, muscle pain, weakness, or cramping; irregular heartbeat; tingling sensation; trouble breathing; dizziness); symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine); tenderness at the transplant site; tremors; trouble walking or talking; unexplained weight loss; unusual lumps or growths; unusual tiredness or weakness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Nulojix:
Nulojix is usually handled and stored by a health care provider. If you are using Nulojix at home, store Nulojix as directed by your pharmacist or health care provider. Keep Nulojix out of the reach of children and away from pets.
- If you have any questions about Nulojix, please talk with your doctor, pharmacist, or other health care provider.
- Nulojix is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Nulojix or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nulojix. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nulojix. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Nulojix.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.